ABSTRACT
Introduction (contexte de la recherche): In Parts A and B of the 3-part phase 3 LIBERTY EoE TREET study (NCT03633617), dupilumab 300 mg weekly (DPL qw) vs. placebo (PBO) demonstrated significant efficacy and acceptable safety up to 24 weeks (wks) in adults and adolescents with eosinophilic esophagitis (EoE). For patients (pts) who completed Parts A or B, Part C was an extended active treatment period for 28 wks. Objectif: To assess the safety and efficacy of DPL in pts who completed Part B and continued to Part C, up to 52 wks. Methodes: Of 80 DPL qw pts in Part B, 74 continued DPL qw in Part C (DPL/DPL). Of 79 PBO pts in Part B, 37 pts received DPL qw in Part C (PBO/DPL). Part B co-primary endpoints were proportion of pts achieving peak esophageal intraepithelial eosinophil (eos) count <= 6 eos/high power field (hpf) and absolute change from Part B baseline (BL) in Dysphagia Symptom Score (DSQ) score at Wk 24. Secondary endpoints included peak eos count, EREFS, and HSS grade and stage scores. In Part C, all co-primary and secondary endpoints were assessed at Wk 52 as secondary endpoints. Safety was also assessed. Resultats: Part B BL characteristics were similar across groups. At Wk 52 of Part C, 84.6% of DPL/DPL and 67.6% of PBO/DPL groups achieved peak eos count of <= 6 eos/hpf and mean (SD) absolute change from Part B BL in DSQ score was -30.26 (15.39) for DPL/DPL and -27.25 (11.46) for PBO/DPL pts. At Wk 52, peak eos count, EREFS, HSS grade and stage scores were reduced, compared with Part B BL, and EDP and T2 NESs were suppressed in DPL/DPL and PBO/DPL groups. Dupilumab demonstrated an acceptable safety profile in Part C;the most common (occurring >= 10%) treatment-emergent adverse events in DPL/DPL and PBO/DPL groups were injection-site reactions (13.5% and 10.8%), COVID-19 (9.5% and 10.8%) and nasopharyngitis (4.1% and 10.8%). Conclusion(s): As observed in Part A/C, dupilumab qw demonstrated persistent improvements in clinical, symptomatic, histologic, endoscopic and molecular features of EoE up to 52 wks and had an acceptable safety profile. PBO pts from Part B who received dupilumab in Part C showed similar efficacy to dupilumab qw pts of Part B.Copyright © 2023